SV DBS Vrain Array

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K111259 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K030317 Active Cleared 25 Mar 2003

• Sv Dbs Brain Array, Model 1500SV-SMS64

  Class II

  FDA 510(k) K090267 Active Cleared 16 Mar 2009

• Special Procedures Head Coil; Model # 1100GE-64

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• Brain Coil, Model 9800GE-64

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• Mep-90 Hair Growth Stimulation System

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• Model 6900GE-64: C-Spine Array

  Class II

  FDA 510(k) K002860 Active Cleared 22 Nov 2000

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• What is the SV DBS VRAIN Array used for?

  The SV DBS VRAIN Array is a specialized MRI receiver coil designed to improve signal detection in deep brain stimulation (DBS) applications. It enhances imaging resolution and contrast for targeted brain regions, aiding in the precise evaluation of DBS electrode placement or related pathologies during MRI procedures.

• Is the SV DBS VRAIN Array reusable or single-use?

  The SV DBS VRAIN Array is supplied as a reusable component. It is intended for repeated use within MRI environments, provided proper cleaning and maintenance protocols are followed to prevent interference or damage.

• What sterility status does the SV DBS VRAIN Array have?

  The SV DBS VRAIN Array is classified as non-sterile. It is not intended for sterile procedures and should be handled and stored according to standard MRI coil protocols to maintain its functionality and safety.

• How should the SV DBS VRAIN Array be stored?

  The SV DBS VRAIN Array must be stored following standard MRI coil protocols to avoid interference or damage. This includes keeping it in a clean, dry environment, away from magnetic fields or sources of electromagnetic interference, and ensuring it is properly secured when not in use.

• What regulatory pathway does the SV DBS VRAIN Array follow?

  The SV DBS VRAIN Array was granted FDA 510(k) clearance (K111259) under the Traditional clearance type, classified as substantially equivalent to a predicate device. It falls under FDA product code MOS and adheres to Special Controls for Class II devices, with an advisory committee review by the Radiology Advisory Committee (RA).